A Study to Assess the Efficacy of Intravenous/Oral Bondronat (Ibandronate) in Patients With Metastatic Bone Disease Experiencing Moderate to Severe Pain

NCT ID: NCT00099177

Last Updated: 2017-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2007-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This 2 arm study will compare the efficacy of a regimen of intravenous (iv) and oral Bondronat with that of zoledronic acid in patients with malignant bone disease experiencing moderate to severe pain. Patients will be randomized to receive either Bondronat (6mg iv on days 1, 2 and 3 followed by Bondronat 5Omg po daily from day 22 to week 24) or zoledronic acid (4mg iv on day 1, and then every 3-4 weeks). The anticipated time of study treatment is 6-12 months, and the target sample size is 100-500 individuals.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain Bone Neoplasm Neoplasm Metastasis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type EXPERIMENTAL

ibandronate [Bondronat]

Intervention Type DRUG

6mg iv on days 1-3, and 50mg po from day 22 to week 24

2

Group Type ACTIVE_COMPARATOR

zoledronic acid

Intervention Type DRUG

4mg iv on day 1, and every 3-4 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ibandronate [Bondronat]

6mg iv on days 1-3, and 50mg po from day 22 to week 24

Intervention Type DRUG

zoledronic acid

4mg iv on day 1, and every 3-4 weeks

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* patients with malignant bone disease;
* patients with moderate to severe pain.

Exclusion Criteria

* patients who have received a bisphosphonate within 3 weeks from the signing of informed consent;
* patients receiving concurrent investigational therapy, or who have received investigational therapy within 30 days of the first scheduled day of dosing;
* untreated esophagitis or gastric ulcers;
* recent or pre-scheduled radiotherapy to bone;
* patients who are pregnant or breast-feeding.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hoffmann-La Roche

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

La Paz, , Mexico

Site Status

Mexicali, , Mexico

Site Status

Mexico City, , Mexico

Site Status

Monterrey, , Mexico

Site Status

Panama City, , Panama

Site Status

Poznan, , Poland

Site Status

Poznan, , Poland

Site Status

San Juan, , Puerto Rico

Site Status

Kazan', , Russia

Site Status

Moscow, , Russia

Site Status

Moscow, , Russia

Site Status

Moscow, , Russia

Site Status

Moscow, , Russia

Site Status

Obninsk, , Russia

Site Status

Saint Petersburg, , Russia

Site Status

Saint Petersburg, , Russia

Site Status

Sankt Gallen, , Switzerland

Site Status

Manchester, , United Kingdom

Site Status

Sutton, , United Kingdom

Site Status

Miami, Florida, United States

Site Status

Macon, Georgia, United States

Site Status

Houston, Texas, United States

Site Status

Bahía Blanca, , Argentina

Site Status

Buenos Aires, , Argentina

Site Status

Buenos Aires, , Argentina

Site Status

Rosario, , Argentina

Site Status

Santa Fe, , Argentina

Site Status

Adelaide, , Australia

Site Status

Brisbane, , Australia

Site Status

Santiago, , Chile

Site Status

Viña del Mar, , Chile

Site Status

Hamburg, , Germany

Site Status

Kalyftaki Kifissia, , Greece

Site Status

Thessaloniki, , Greece

Site Status

Guatemala City, , Guatemala

Site Status

Budapest, , Hungary

Site Status

Budapest, , Hungary

Site Status

Deszk, , Hungary

Site Status

Szeged, , Hungary

Site Status

Rozzano, , Italy

Site Status

Torino, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Argentina Australia Chile Germany Greece Guatemala Hungary Italy Mexico Panama Poland Puerto Rico Russia Switzerland United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BO18039

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.